Study for the low and intermediate risk of Neuroblastoma
- Conditions
- INTERMEDIATE AND LOW RISK NEUROBLASTOMATherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2010-021396-81-LT
- Lead Sponsor
- INSTITUTO DE INVESTIGACIÓN SANITARIA LA FE DE VALENCIA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 685
Informed consent and follow-up warranted; group assignment completed within 6 weeks from diagnosis; no prior chemotherapy or radiotherapy.
Biopsy proven neuroblastoma.
Tumour material available for biological studies according to guidelines.
Age less than or equal to 90 days when the suprarenal mass is discovered.
No regional involvement: MRI scan does not show evidence of positive ipsi/contralateral lymph nodes or other spread outside the suprarenal gland.
No metastatic involvement.
Availability to do the adequate follow-up
Are the trial subjects under 18? yes
Number of subjects for this age range: 685
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Diagnosis of ganglioneuroma or ganglioneuroblastoma intermixed.
Age older than 90 days.
Regional involvement; metastatic involvement.
Inability to undertake mandatory diagnostic studies.
Follow-up not guaranteed by parents/guardians.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method